Standards

The following are links to the list of national and international medical device standards recognized by the Therapeutic Products Directorate (TPD) and related information. Unless otherwise indicated, the complete standard, including appendices and attachments, is recognized. The email contact for the sponsor of the standards list is standards.committee@hc-sc.gc.ca

• List of Recognized Standards for Medical Devices
  Date: 2022-11-15
• Notice - Additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada's List of Recognized Standards
  Date: 2012-07-31
• Guidance Document - Recognition and Use of Standards under the Medical Device Regulations
  Date: 2006-09-22
• Declaration of Conformity
  Date: 2006-09-22

Health Canada consults with the general public and its stakeholders on the above mentioned Medical Devices Standards. More information on these consultations can be found on the Medical Devices Consultation page.